FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraClean
DI: 10653405033264
·
Model: 139108
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- UltraClean
- Primary DI
- 10653405033264
- Version / Model
- 139108
- Catalog Number
- 139108
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-07-14
- Public Version
- 7
- Public Version Date
- 2024-08-01
- Public Version Status
- Update
- Public Device Record Key
- 4fb0fb96-97a7-484f-8ec3-561061781662
Device Description
UltraClean Accessory Electrode 6" (15.24 cm) Coated Needle with Extended Insulation
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61874 | Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20653405033261 | GS1 | BOX | 50 | In Commercial Distribution | |
| Primary | 10653405033264 | GS1 | ||||
| Unit of Use | 00653405033267 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 32 Degrees Celsius